Samer Al Hadidi: The longest follow up of any myeloma phase III clinical trial
Samer Al Hadidi, Assistant Professor at UAMS Myeloma Center, shared a post on X:
“We report UAMS Myeloma Center the longest follow up of any myeloma phase III clinical trial.
Long Term Follow up of Total Therapy IV: A Phase III Clinical Trial for Standard Risk Multiple Myeloma.
Median OS: 13.3 yrs.
The initial report of the study was published.
Median follow up at initial publication was 4.5 years.
N=380 patients.
Median follow up for the L arm: 13.1 years, S arm: 11.1 years and for all pts 12 years.
Of note after enrolling 289 pts and no difference in outcome (less infections with S arm) with fractionation of MEL, all remaining pts were enrolled in S arm (hence shorted follow up in S arm).
No difference between both arms and the group that was not randomized.
Mean (SD) of the age of enrolled pts: 59 (9.4) yrs with age range: 30-76 years.
12% Black patients enrolled.
Median OS of 13.3 years (95 CI: 12.5-NR).
10-yrs PFS: 41%.
Risk of 2ry heme malignancies was not different between 1 vs 2 (tandem) transplants -actually it was lower with tandem.
Patients who did tandem transplants (the majority) had better outcomes than those who got 1 transplant ( this study was not designed/aimed to ask if 2 better than 1).
No anti-CD38 was used in this study.
RVD was used for 3 years after transplants and then stopped (time limited therapy).
MRD introduced in 2012 in UAMS Myeloma Center and from enrolled pts 2 out of 3 achieved sustained MRD negativity.
We will have future work on late progression events (those who progress after 10 years while off therapy).
Cc: Meera Mohan, Anup Trikannad, Asis Shrestha, Sruthi Vellanki.
This is a relatively infrequent event and when it happens sometimes can be monitored without therapy.
Bart Barolgie developed the total therapy program and we are thankful for his vision (more work to come).
We are thankful to all patients who continue to come once a year for comprehensive workup.
I am thankful for all the research team who helped in this, following phase 3 trial for that long is not easy.”
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